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Environmental Health & Safety Manual (EHS)

Effective: 1/1/2006

Revised: 3/1/2015

EHS 114: Biosafety Serum
Storage Program

Purpose

To establish and maintain ASU’s Biosafety Serum Storage Program, which
involves the collection of reference baseline serum
samples from personnel working with hazardous research
material based on their job responsibilities

Background

The ASU Biosafety Serum Storage Program represents research best practices as recommended by the Centers
for Disease Control and Prevention and the National Institutes of
Health

Department of Health and Human Services. National
Institutes of Health. Guidelines for Research Involving
Recombinant and Synthetic Nucleic Acid Molecules. November, 2013

Arizona State University Biosafety
Manual

Applicability

ASU academic, research, and other operations employees working
in areas deemed to be high risk and as otherwise recommended by the campus
Biosafety Officer and/or the Institutional Biosafety Committee (IBC)
in consultation with ASU Health Services.

Policy

Responsibilities of the University

ASU has instituted and maintains a biosafety program for the
possession, use, transfer, and storage of biohazards and for
employees who may be exposed to biohazards during the
performance of their duties. The biosafety program is designed to
promote and achieve regulatory compliance and provides a means for
personnel to be better informed about and protected from
biohazards. Whenever occupational exposure to human pathogens is a risk, ASU will offer the ability to collect and store a serum specimen prior to the initiation of work with the agent. The serum sample may be used to establish baseline sero-reactivity. At a minimum, serum banking is offered to personnel with agents classified as Biosafety Level (BSL)-3/Animal Biosafety Level (ABSL)-3 or when using certain agents classified as BSL-2/ABSL-2.

Responsibilities of the Department of
Environmental Health & Safety

The university Biosafety Officer (BSO) is responsible for
providing assistance to the IBC, in consultation with ASU Health Services, for
the purpose of risk assessment, identification, and recommendation
for participation in the Serum Storage Program.

Responsibilities of the Institutional Biosafety
Committee (IBC)

The IBC is a resource to the university community for supporting the responsible conduct of biohazardous research and oversees research and teaching activities involving the use of infectious materials and microoganisms in research and teaching. The IBC is registered with the National Institutes of Health Office of Biotechnology Activities (OBA) and is responsible for university compliance with the Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). The IBC reports to the senior vice president for Knowledge Enterprise Development. More information on the committee can be found on the Reseach Itegrity and Assurance website.

Responsibilities of ASU Health Services

ASU Health Services is responsible for drawing the sera for research and operations personnel and maintaining all records associated with the samples. No clinical
or diagnostic testing will be requested at the time of the initial
banking. Specimens will be processed in accordance with recommendations
of the College of American Pathology. Access, inventory, and control of the sera is
defined in the “Procedures” section of this
document. ASU Health Services will dispose of the samples as medical waste 30
years from date of collection, or after notification that the individual
left the university at least 10 years ago, or at the individual’s request.

Responsibilities of Departments and
Units

Deans, Directors, and Chairs

Deans, directors, and chairs of colleges, departments, and other
units have the primary responsibility for the biosafety and biosecurity of people,
animals, and the environment within their jurisdiction.

Principal Investigators

Principal Investigators (PI) using or storing biohazardous
materials are responsible for taking all reasonable and practicable action to protect
the health and safety of those working with the materials. The
researcher must complete and submit registration forms to the
IBC for all research proposals
involving the use of biohazards and develop specific biosafety
standard operating procedures for each biohazard used in the
laboratory.

The PI should take all reasonable and practicable action to:

ensure laboratory personnel participate in the necessary medical
surveillance program, including identifying positions for which this
program is applicable and including the serum storage
recommendation in appropriate department or research
documentation

ensure laboratory personnel sign the consent for
participation or acknowledge their declination

refer eligible personnel to the ASU Health Services to have
their blood drawn

provide training and instruction specific to the research
hazards as well as safe practices and protocols, including, at a
minimum, training in aseptic techniques and biology of the
organism(s) being used